跳至主要内容
临床试验/NCT02634372
NCT02634372已完成不适用

Single-blind, Randomized Controlled Comparison of EMDR Versus Supportive Therapy in Affective Relapse Prevention in Bipolar Patients With a History of Trauma

FIDMAG Germanes Hospitalàries2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2016年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
82
试验地点
2
主要终点
Number of depressive, hypomanic, manic or mixed episodes

研究概览

简要总结

The purpose of this study is to determine whether EMDR (vs supportive therapy) is effective in relapse prevention over an observational period of 2 years in bipolar patients with a history of traumatic events.

详细描述

Background:

The intervention strategies available for bipolar disorder are essentially pharmacotherapy and psychosocial interventions such as cognitive behavioral therapy, psychoeducation, and interpersonal and family therapy. However, despite the everyday use in clinical practice of both types of intervention, almost 70% of patients with bipolar disorder suffer an affective relapse within two years. Although the origin of this is multi-causal, an emerging research topic is the association of bipolar disorder with posttraumatic stress disorder (PTSD). Data from the STEP-BD study showed a prevalence of 20% of PTSD in a sample of 3158 bipolar patients, a rate almost three times higher than the prevalence of PTSD in the general population. This comorbidity has important clinical implications as the traumatized bipolar patients suffer from more rapid cycling, more suicide attempts, more substance abuse, have lower quality of life and more (hypo) manic and depressive symptoms than bipolar patients without PTSD. The results are similar in populations with severe mental illness and a history of trauma (not necessarily diagnosis of PTSD). These populations have more affective episodes, more psychiatric symptoms, increased risk of suicide, more frequency of risk sexual behaviors, more admissions to psychiatric hospitals and in overall, a greater risk of being re-traumatized.

The strength of the evidence supporting the clinically relevant effects of PTSD and/or history of trauma in bipolar disorder contrasts with a surprising lack of trials aimed at treating patients who have experienced traumatic events. One form of treatment that is being increasingly used in PTSD therapy is Eye Movement Desensitization and Reprocessing (EMDR). This integrative psychotherapeutical approach uses standardized protocols and elements of cognitive-behavioral, interpersonal, and body-centered therapies in conjunction with dual stimulation (e.g. horizontal eye movements from side to side). The results of two independent meta-analyzes have shown that the EMDR therapy is as effective in the treatment of PTSD symptoms as cognitive behavioral therapy. The treatment with EMDR has also been tested successfully versus exposition therapy and waiting list in a large randomized controlled trial in patients with psychosis and PTSD. Their results showed a significant reduction of trauma scores in both intervention in comparison to the waiting list and both intervention were regarded as safe with respect to exacerbation of psychotic symptoms. Our group carried out the first randomized controlled pilot study of EMDR in bipolar traumatized patients with subsyndromal symptomatology. Our results showed that the EMDR intervention not only reduced the symptoms associated with trauma in the patients, but also had beneficial effects on the symptoms of subsyndromal mood. Following the results this study, our research group has developed a specific and comprehensive EMDR protocol for bipolar patients with a history of trauma. This protocol consists of a comprehensive survey of traumatic events, the intervention and processing of these events according to the Shapiro standard protocol and 5 sub-protocols directed to (a) enhance treatment adherence, (b) increase insight, (c) treat prodromal symptoms, (d) work on the de-idealization of manic symptoms and (e) provide mental stabilization.

Aims and hypotheses:

The main objective of this study is to examine if EMDR therapy with protocols specific to bipolar patients with a history of traumatic events can act as a mood stabilizer. This would result in less affective relapses and better overall and cognitive functioning after 6 months of therapy in the group that received EMDR submit compared with the ST group. Other related aims of this project are to expand the available options for psychosocial intervention in bipolar disorder, to demonstrate that the EMDR therapy is a safe and effective tool in traumatized bipolar patients and that treatment with EMDR lead to an improvement in the course and prognosis of the disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients fulfill diagnosis of bipolar I or II disorder, following DSM-IV-RT criteria
  • Outpatients
  • History of 2 to 6 affective episodes in previous year
  • Patients are included in the study 1) in euthymia, defined as Bipolar Depression Rating Scale (BDRS) <8 and Young Mania Rating Scale (YMRS) <8 or 2) with subsyndromal symptoms, defined as BDRS ≥8 and <14 and/or YMRS ≥8 and <12
  • Patients suffered at least from one traumatic event, evaluated by the Distressing Event Scale, Traumatic Life Events Questionnaire, Impact of Event Scale and Subjects Units of Distress.

排除标准

  • Neurological disease
  • Currently in a manic phase (YMRS>18), mixed phase (BDRS≥10 in mixed subscale of BDRS, max.: 15) or depressive phase (BDRS >18)
  • Acute suicidal plans
  • Substance Use Disorder within last 3 months (except of nicotine abuse/dependency)
  • Trauma focused therapy within last 12 months.

结局指标

主要结局

Number of depressive, hypomanic, manic or mixed episodes

时间窗: Change of relapses from baseline to visits at 6, 12 and 24 months

Affective relapses are defined as: Depressive relapse: score\>18 in the BDRS, and a score\>3 in the CGI-BP-M, depressive subscale. Hypomanic relapse: a YMRS score between 7 and 20, and a score of 3 or 4 in the CGI-BP-M, the manic subscale. Manic relapse: a YMRS score of \>20, and the CGI-BP-M, the manic subscale, score\>4. Mixed relapse: a BDRS score\>10 in the mixed subscale (max. 15), and a score \>4 in the CGI-BP-M, depressive and manic subscales.

次要结局

  • Trauma associated symptoms(Change from baseline in trauma symptoms at 3, 6, 12 and 24 months)
  • Cognitive impairment(Change from baseline in cognition at 3, 6, 12 and 24 months)
  • Functioning(Change from baseline in functioning at 3, 6, 12 and 24 months)
  • Depressive symptoms(Change from baseline in depressive symptoms at 3, 6, 12 and 24 months)
  • (Hypo)manic symptoms(Change from baseline in (hypo)manic symptoms at 3, 6, 12 and 24 months)
  • Mixed symptoms(Change from baseline in mixed symptoms at 3, 6, 12 and 24 months)
  • Social cognition and emotional intelligence(Change from baseline in cognition at 3, 6, 12 and 24 months)

研究者

发起方
FIDMAG Germanes Hospitalàries
申办方类型
Other
责任方
Principal Investigator
主要研究者

Benedikt Lorenz Amann

Senior Research fellow

FIDMAG Germanes Hospitalàries

研究点 (2)

Loading locations...

相似试验